Cited by 381Hormonal and reproductive studiesAdrenal Hormones and DisordersHypothalamic control of reproductive hormones

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Pharmacokinetics, Efficacy, and Safety of a Permeation-Enhanced Testosterone Transdermal System in Comparison with Bi-Weekly Injections of Testosterone Enanthate for the Treatment of Hypogonadal Men

Dobs, A. S.·1999·Journal of Clinical Endocrinology & Metabolism

DOI 10.1210/jc.84.10.3469

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Abstract

The pharmacokinetics, efficacy, and safety of the Androderm testosterone (T) transdermal system (TTD) and intramuscular T enanthate injections (IM) for the treatment of male hypogonadism were compared in a 24-week multicenter, randomized, parallel-group study.Sixty-six adult hypogonadal men (22-65 years of age) were withdrawn from prior IM treatment for 4 -6 weeks and then randomly assigned to treatment with TTD (two 2.5-mg systems applied nightly) or IM (200 mg injected every 2 weeks); there were 33 patients per group.Twenty-six patients in the TTD group and 32 in the IM group completed the study.TTD treatment produced circadian variations in the levels of total T, bioavailable T, dihydrotestosterone, and estradiol within the normal physiological ranges.IM treatment produced supraphysiological levels of T, bioavailable T, and estradiol (but not dihydrotestosterone) for several days after each injection.Mean morning sex hormone levels were within the normal range in greater proportions of TTD patients (range, 77-100%) than IM patients (range, 19 -84%).Both treatments normalized LH levels in approximately 50% of patients with primary hypogonadism; however, LH levels were suppressed to

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Authors: Dobs, A. S.
Affiliations: Johns Hopkins University (US)
ORCID: Dobs, A. S.
Venue: Journal of Clinical Endocrinology & Metabolism
Publisher: The Endocrine Society
Published: 1999-10-01
Volume: 84
Issue: 10
Pages: 3469-3478
ISSN: 0021-972X (ISSN-L)
DOI: 10.1210/jc.84.10.3469
OpenAlex: W2148714770
Cited by: 381
References: 32
Citations by year: 2026: 5 · 2025: 2 · 2024: 10 · 2023: 7 · 2022: 9 · 2021: 9 · 2020: 13 · 2019: 11 · 2018: 9 · 2017: 11 · 2016: 11 · 2015: 22 · 2014: 12 · 2013: 12 · 2012: 21
FWCI: 8.06
Type: journal article
Language: en
Open access: closed
Locations: The Journal of Clinical Endocrinology & Metabolism (publishedVersion)
PubMed (publishedVersion)
Funders: University of South Florida
Svenska Läkaresällskapet
National Institutes of Health
Medical Research Council
National Center for Research Resources (5M01 RR 00722, M01RR000722, RR-0003524)
Topics: Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Hormonal and reproductive studies
Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Adrenal Hormones and Disorders
Health Sciences › Medicine › Reproductive Medicine › Hypothalamic control of reproductive hormones
Keywords: testosterone replacement therapy, male hypogonadism, transdermal testosterone, testosterone enanthate, intramuscular injection, pharmacokinetics, sex hormone levels, LH suppression, estradiol, dihydrotestosterone, gynecomastia, hematocrit, skin irritation, sexual function, depression, hypergonadotropic hypogonadism
MeSH terms: Administration, Cutaneous, Adult, Aged, Drug Administration Schedule, Hematocrit, Humans, Hypogonadism, Injections, Intramuscular, Male, Middle Aged, Permeability, Prostate, Testosterone, Treatment Outcome

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Pharmacokinetics, Efficacy, and Safety of a Permeation-Enhanced Testosterone Transdermal System in Comparison with Bi-Weekly Injections of Testosterone Enanthate for the Treatment of Hypogonadal Men

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